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Medical Device Cleanrooms

American Cleanroom Systems® is an expert on medical device, pharmaceutical, nutraceuticals and medical supplier cleanrooms.

Past industry clients have included:

  • Allergan
  • Baxter
  • DuPont
  • Johnson & Johnson
  • Calhoun Vision
  • Medtronic
  • Siemens Medical
  • Applied Medical
  • Burpee Medsystems
  • Confluent Medical
  • Meditech
  • Paragon Vision
  • Parker Laboratories
  • Tenex Health

ACS cleanroom options for medical device cleanrooms:

  • FRP modular panels for chemical resistance
  • Anodized aluminum frame components including internal electrical raceway
  • Proprietary ACS coved corner
  • Proprietary ACS coved window frame
  • Heat welded vinyl floor with integral cove
  • Room side replaceable HEPA fan filter units
  • Material pass thru’s
  • Cart cart pass thru’s
  • Door interlock systems
  • Temperature and humidity AC systems

American Cleanroom Systems® has a track record of delivering clean room solutions for a large number of world-class medical related companies. We deliver on time and on budget at very competitive prices. Contact us today and we’ll discuss your requirements and submit a project quote within 48 hours.

American Cleanroom Systems® Common Cleanroom Class Choices

Type Of Process Clearoom Class
Aseptic manufacturing and filling Class 100/ISO5
Assembly and packaging of devices that will be terminally sterilized where low particle count on devices is desired Class 10,000/ISO7
Convenience kits and assembly of medical devices that need to be free of visible particles Class 100,000/
ISO8/controlled environment
Manufacturers that repackage and/or re-label unpackaged bulk devices contract sterilizers, and re-manufacturers that change the original condition of devices Subject to QS (Quality Systems)/
GMP (Good Manufacturing Practices)
Pharmacy Drug compounding (per USP website) Class 100 hood in class 10k room
Monitoring Method
Air – Particle count Air sampler (particle counter)
Work surfaces – microbes Surface contact plates or settling plates
Airborne particulate cleanliness FED-STD-209E
Personnel training 820.25 ( QS)
Buildings 21 CFR 820.70 (QS)
Cleaning Procedures CFR 820.70 (QS)
Pharmacy Drug compounding USP797

Per FDA factors to consider when planning and using a controlled environment:

  • proper attire and dressing anteroom;
  • controlled use of, and entry into, controlled areas;
  • prohibiting eating, drinking, smoking, or gum chewing;
  • preventing use of lead pencils;
  • regulating the storage of glassware and containers;
  • preventing or controlling the cutting, tearing or storage of cardboard, debris, etc.;
  • cleaning the room and production equipment per written procedure;
  • the original design and cleaning of work surfaces and chairs;
  • selecting correct furniture and eliminating all nonessential equipment;
  • controlling room air quality (amount of particulates, pressure, velocity, and exchange rate);
  • eliminating electrostatic charges by controlling work surface composition or grounding;
  • ensuring cleanliness of raw materials, components and tools;
  • controlling the purity, sterility, and non­pyrogenicity of process water; and
  • maintaining prefilters, HEPA filters, and electrostatic precipitators.

American Cleanroom Systems® modular clean room walls made of FRP (reinforced plastic) and HPL (high pressure laminate) are often used in pharmaceutical, USP 797 compounding rooms, and medical device clean rooms. They can be wiped down with antiseptic. This wall system is an economical and cost effective method to achieve the FDA GMP 9 (QS) and USP 797.

American Cleanroom Systems® also offers standard built seamless epoxy coated cleanroom walls with coved flooring to handle more robust mop down wall cleaning/disinfectant procedures.

FAQs About Medical Device Cleanrooms

Q: What is a medical device cleanroom?

A: A medical device cleanroom is a cleanroom where medical devices – both implantable or for external use – are manufactured. It also can refer to the cleanroom of suppliers (like a plastic injection molder)  to the medical device company.

Q: Who regulates medical device cleanrooms?

A: The FDA  requires that medical devices be manufactured under FDA GMP (Good Manufacturing Practice) rules. Some medical device is subject to FDA validation which includes manufacturing processes, equipment, and facilities (like cleanrooms).

Q: What cleanroom classification are medical device cleanrooms?

A: Medical device cleanrooms classification can range from ISO-5 to ISO-8 depending on the criticality of the product, whether it is implantable, and sterility requirements. Determination of correct cleanroom classification is done under FDA GMP rules. Most common cleanroom classification are ISO-7 and ISO-8.

Q: Do medical device cleanrooms have air conditioning?

A: Yes. GMP requires a controlled environment. Typically, there is some kind of medical device manufacturing specification for allowable temperature and humidity that can only be achieved with cleanroom air conditioning.

Q: What kind of cleanrooms are used for product that are supplied to medical device companies?

A: Plastic injections molders are typically ISO-8. Supplier cleanroom requirements are dictated by the medical device company depending upon what cleaning and sterilization steps are done to the components after they arrive at medical device company. Suppliers to implantable device medical device companies typically are required to have the higher classification cleanrooms.

Q: What is final sterilization in a medical device cleanroom?

A: Often the final step of medical device manufacturing is sterilization prior to packaging. The packaging step is often done in an ISO-5/class 100 cleanroom environment to ensure that no contamination gets on the product during packaging.

Q: What are requirements if I am manufacturing implantable medical device?

A: Implantable medical devices come into contact with tissue and membrane. They must be sterile and contaminant free to protect the patient from infection. Implantable medical devices must be manufactured in minimum ISO-7/class 10k cleanroom to ensure cleanliness and quality. 

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